Articles in FDA
Senators Call for Medical Device Makers to Disclose Post-Market Safety Monitoring Procedures
U.S. Senators Charles Grassley, Richard Blumenthal and Herb Kohl have introduced the Medical Device Patient Safety Act, designed to give the Food and Drug Administration (FDA) tools to better monitor post-market performance of new medical …
Congressmen Seek Review of Medical Device Regulation
Bloomberg Businessweek reports, House Democrats on the Energy and Commerce Committee, led by Representative Henry Waxman of California, sent a letter to Republicans leaders urging an investigation on the safety of metal-on-metal medical devices.
Parents File Lawsuit Against Simply Thick
As reported in Las Cruses Sun-News, local couple Shane and Jennifer Umphress filed a lawsuit yesterday against Simply Thick, LLC, the manufacturer of a breast milk and formula-thickening agent for infants.
FDA Advisory Panel to Discuss Safety of Transvaginal Mesh
Bloomberg reports that transvaginal mesh lawsuits are on the rise, and that a two-day hearing on their safety and effectiveness will begin tomorrow. An advisory panel “won’t take any formal votes,” but the “FDA will poll the panel of researchers and physicians on whether to reclassify the devices and gather thoughts on how to conduct clinical studies.”
Long-Term Use of Osteoporosis Drugs and Increased Risk of Fractures
In February 2011, the JAMA published a study finding that long-term osteoporosis treatment with bisphosphonates increases the risk of rare femur fractures
Frequent Use of Over-the-Counter Painkillers Poses Serious Health Dangers
The U.S. Food and Drug Administration states more than 50% of patients do not take over-the-counter medication as directed. Research confirms that overdosing on over-the-counter painkillers may lead to organ failure, strokes, and even death.
Pain Killers & Liver Failure: FDA Restricts Acetaminophen in Some Products
The FDA is restricting the amount of acetaminophen in the nation’s most popular prescription painkillers based on the use of over-the-counter painkillers containing acetaminophen such as Tylenol, and the link between thousands of cases of liver damage.
Diabetes Drug Avandia : Drug Maker’s Study Under Investigation
The New York Times reported this week that GlaxoSmithKline, the maker of Avandia, a prescription drug intended for the treatment of Type 2 diabetes, undertook a secret study in 1999 that it has attempted to keep unknown for the past 11 years.
Diabetes Drug Avandia and Strokes and Heart Attacks: Further Evidence of Link
The Los Angeles Times reported that the prescription diabetes drug, Avandia, is linked with an increased risk of hearts attacks, heart failure and strokes, as released in two independent recent study findings.
Avandia Diabetes Drug And Patient Heart Attacks Linked, New York Times Reports
Confidential government reports disclosed to the New York Times recommend that the diabetes drug Avandia be removed from the market because of the significant risk of heart attacks and the availability of a safer alternative drug.
Medtronic Heart Lead Recall Update: “[Sprint] Fidelis lead fracture rate is increasing exponentially with time”
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In March 2009, Medtronic disclosed that at least 13 Sprint Fidelis patients may have died, including four patients whose deaths were related to efforts by doctors to surgically remove the product. In February 2010, the Wall Street Journal reported that the FDA database includes at least 12 additional deaths allegedly linked to the recalled device.
Aranesp, Epogen and Procrit Anti-Anemia Drugs Linked to Strokes and Heart Attacks
Facing evidence of increased risks of stroke and heart attack among patients using high doses of certain anti-anemia drugs, the FDA has announced it will ask outside experts to re-examine the safety and proper dosage of Aranesp, Epogen and Procrit
Studies spotlight problems in FDA device approvals for devices like pacemakers, heart stents
Two new studies find shortfalls in the Food and Drug Administration’s approval process for heart devices such as pacemakers and stents
Medical Dyes for MRIs and Link to Nephrogenic Systemic Fibrosis (NSF)
Exposure to certain medical dyes used in MRIs has been linked to the development of the debilitating disease Nephrogenic Systemic Fibrosis
Reglan’s Dangerous Side Effect: Tardive Dyskinesia
The prescription drug Reglan has been linked to Tardive Dyskinesia (TD), a neurological disorder which can include involuntary spasms and movements.
